Cardiopulmonary Bypass, Congenital Heart Disease, Cyanotic Heart Disease, Endocarditis Acute and Subacute, Open Heart Surgery
Conditions
Brief summary
The Localized Evidence of Cytokine Adsorption Therapy (LEAT) study is a prospective, randomized controlled trial conducted at the Institut Jantung Negara in Malaysia. It evaluates the efficacy and safety of using Jafron HA-60 and HA380 hemoadsorption cartridges to reduce systemic inflammation in pediatric patients undergoing major heart surgery. Objective This study aims to compare the post-operative inflammatory response in children undergoing cardiac procedures treated with or without a cytokine. Study Population All children \< 18 years of age at the time of enrollment who are scheduled to undergo cardiac surgery involving cardiopulmonary bypass (CPB) with an expected duration of \>180 minutes. Methodology This single-center study will randomly assign patients before surgery into 2 groups: 1 group will receive hemoadsorption treatment plus with standard-of-care (intervention group), while the other group will receive standard-of-care (control group) only. Primary Endpoint: To evaluate changes in IL-6 plasma concentrations over the first 24 hours following the procedure. Analysis will be performed using a linear mixed-effects model (LMM) to capture both between-subject and within-subject variability across repeated time points. This method allows assessment of the overall trajectory of IL-6 and provides a clearer understanding of its temporal pattern throughout the 24-hour post-procedure period. Secondary Endpoints: 1. Changes cytokines (IL-8, IL-10, IL-1β, and TNF-α) plasma levels over 24 hours 2. PELOD-2 score on ICU admission, at 48 hours post ICU admission 3. ICU and hospital length of stay 4. ICU, hospital, and 28 days mortality 5. Mechanical - ventilation (MV) free days at day 6. Renal replacement therapy (RRT) free days at day 28 7. Vasopressors free days at day 28 8. Acute kidney injury 9. Bleeding complications 10. Post operative liver injury Data Collection: Blood samples will be taken at five timepoints: before surgery, at ICU admission, and at 6, 24, and 48 hours post-procedure . Duration: The study is expected to last 24 months.
Interventions
DEVICEHemoadsorption (Jafron HA-60/HA380)
Participants will receive hemoadsorption therapy using a Jafron HA-60 or HA380 cartridge in addition standard of care integrated into the cardiopulmonary bypass (CPB) circuit during surgery. The specific cartridge is chosen based on the patient's weight. The device works to filter out inflammatory proteins (cytokines) from the blood while the patient is on the heart-lung machine. This treatment starts at the beginning of the bypass and ends when the bypass is completed.
Sponsors
Norfaniza Zabidi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
This is an open-label study where the treatment assignment is known to the participants, the surgical and perfusion teams (care providers), and the investigators. Due to the nature of the intervention, which requires the physical integration of the Jafron HA-60 or HA380 cartridge into the cardiopulmonary bypass circuit, blinding of the clinical team is not feasible.
Intervention model description
The LEAT study employs a prospective, single-center, randomized controlled trial design with a parallel-group assignment. This model was chosen to ensure a direct comparison between the intervention and the current gold standard of care. * Randomization & Allocation: Eligible pediatric patients are assigned to either the intervention or control group in a 1:1 ratio. * Parallel Execution: Participants in the Intervention Group receive hemoadsorption therapy utilizing the Jafron HA-60 or HA380 cartridge, which is integrated directly into the cardiopulmonary bypass (CPB) circuit. Participants in the Control Group receive the standard institutional perioperative care. Both groups are monitored and managed concurrently under identical clinical conditions. * Treatment Duration: The intervention is strictly localized to the intraoperative phase. The hemoadsorption process occurs continuously from the initiation of CPB until the termination of the bypass procedure.
Eligibility
Sex/Gender
ALL
Age
0 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Children (\<18 years old at study inclusion) * Undergoing a cardiac surgery with CPB of expected duration \> 180min * Prophylactic application of HA during CPB for suspected SIRS.
Exclusion criteria
* Non-ability to gather informed consent from parents or legal representative. Enrolled in conflicting research study * Off-pump procedure * Non-steroidal anti-inflammatory treatment in the previous 7 days Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Localized Evidence of Cytokine Adsorption Therapy During Pediatric Cardiac Surgery: A Single Center Randomized Controlled Trial (LEAT) | 24 Months | To evaluate changes in IL-6 plasma concentrations over the first 24 hours following the procedure. Analysis will be performed using a linear mixed-effects model (LMM) to capture both between-subject and within-subject variability across repeated time points. This method allows assessment of the overall trajectory of IL-6 and provides a clearer understanding of its temporal pattern throughout the 24-hour post-procedure period. |
Contacts
CONTACTSivakumar Sivalingam
CONTACTIrni Yusnida Md Rashid
Outcome results
None listed